FDA Jurisdiction

Subject: Request to clarify Federal and FDA jurisdiction, and to notify local and state authorities regarding legal issues and Jurisdiction over the regulation of Federal law regarding FDA approved medical devices.

As we discussed today, here is my

Request to clarify Federal and FDA jurisdiction, and to notify local and state authorities regarding legal issues and Jurisdiction over the regulation of FDA approved medical devices.

I believe that the working group and petitions I have sent in to the FDA may be the last opportunity the FDA will have to protect the public health from the misuse of these FDA approved medical devices. The issues I'm discussing with the FDA extend to the reuse and reprocessing of ALL FDA approved medical devices. My requests, petitions and emails do Not ask the FDA to do anything more or anything less than to regulate the SAME types of users and practitioners (medical Doctors and their technicians) that the FDA has in fact regulated before these Devices were approved. The same problems the FDA pointed out that occured before devices were FDA approved and before clinical trials are in fact occuring with the same or similar FDA approved medical devices.

In addition my opinion is that anything done by a medical Doctor that violates any laws (whether Federal, state or local) OR any medical ethics OR in any way breaches medical ethics (including, but not limited to the Belmont report, Helsinki guidelines, and Nuremberg code) by definition is Not the practice of medicine. By definition, anything that is Not the practice of medicine does Not afford anyone protection from the law under practice of medicine principles. An off-label use MUST HAVE a patient benefit and be "safe" and "effective" for it to be a practice of medicine. Clearly reusing microkeratome blades is Not and thus the FDA does have jurisdiction (in my opinion). Equally important is any violation of the IRB guidelines used for the clinical trials and/or the labeling, operators manuals, etc. for these approved medical devices. If it was up to me, the FDA and the CDC would state clearly that patient injuries caused by violations of the "safety" and "effectiveness" guidelines submitted to the FDA and obvious medical principles (sterilization) will be enforced by the Federal government- both civilly and criminally.

In addition, Local and state authorities are Not as familiar with regulated medical devices or Federal law as the Federal Government so this request is for the FDA to be helpful by letting them know what jurisdiction they have and the specific laws (or types of laws) they can enforce and in the FDA's opinion need to enforce to protect the public from injury (the public health). As a third party who is directly effected and is interested in open government and notifying the public (see www.lasikliberty.com ), I would also appreciate it if the FDA could copy me on the letters to any authorities in GA or SC and/or provide the information directly addressed to me.

One other reason why I believe the FDA does have authority over violations of Federal laws regarding FDA regulated medical devices is that the FDA does in fact regulate medical Doctors who use medical devices that are Not FDA approved. Frankly, I do Not even understand why anyone at the FDA would question the FDA's jurisdiction given that the FDA has already established its jurisdiction and written a letter to Ophthalmologists regarding "black box" and "gray box" lasers (http://www.fda.gov/cdrh/laser797.html).

The reason I feel that the FDA either does Not understand their authority or is Not being truthful is that the FDA's jurisdiction and authority of medical Doctors should INCREASE after a medical device is approved by the FDA, not decrease. Obviously the FDA has the same jurisdiction over the same users and practictioners after FDA approval as before approval. "Both 'black box' and 'gray market' lasers for refractive surgery are unapproved Class III medical devices that can be used on patients only after FDA has approved an IDE for a clinical trial. " Both before and after FDA approval, the stated purpose is "that patients receive the safest treatment possible" (http://www.fda.gov/cdrh/laser797.html). If the FDA enforces Federal laws and regulates the users and practitioners BEFORE FDA approval, but Not after FDA approval then does the FDA approval mean the FDA knowingly allows approved medical devices to be used in an unsafe and uneffective way that harms patients? The effect of FDA approval would be that the FDA is in effect providing a Federal approval (by looking the other way so to speak) to harm patients and the public health without any Federal or FDA enforcement at all. If the FDA has jurisdiction before approval, then the FDA has EVEN MORE jurisdiction after approval.

If the FDA in fact has No jurisdiction after approval, then I believe the FDA is putting the interests of the FDA and the companies who have obtained approval ahead of the interests of the patients and the public health. If there's any question which is more important or within the FDA's jurisdiction, then based on the FDA's stated mission and objectives and the fact that it is a government agency means that the patients and the public health have to come first. Everyone makes mistakes. If the FDA has erred, then it is important to clarify this error as quickly and clearly as possible. The FDA does Not have to admit the error- just move to correct the situation with as much clarity as possible.

Clearly the FDA does have jurisdition over practices that are outside the labeling or Not "safe" and "effective" if they result in "injuries requiring corneal transplantation, additional (and repetitive corneal surgery), severe night vision problems, and frequent overcorrections ( >+2.00D)" and in my opinion regarding other serious patient injuries as well (dry eye, LASIK flap problems, vision quality problems, etc.).

First, we [the FDA] have uncovered through our own investigations what appears to be a pattern of serious patient injuries attributed to the use of some "black box" lasers. These include several injuries requiring corneal transplantation, additional (and repetitive) corneal surgery, severe night vision problems, and frequent overcorrections ( >+2.00D). These injuries and overcorrections appear to be caused by a laser beam that has a relatively small optical zone, has considerable inhomogeneity, and produces a non-spherical ablation pattern. The injuries from "black box" lasers demonstrate the importance of evaluating the safety and effectiveness of lasers for refractive surgery with a limited number of patients under an FDA-approved Investigational Device Exemption (IDE) and the oversight of an Institutional Review Board, as required by the Federal Food, Drug, and Cosmetic Act (the Act). Data from such studies is critical in establishing the risks and benefits of particular laser designs.

In addition, "black box" lasers may not have adequate fail-safe mechanisms and equipment hazard analyses; furthermore, software validation and verification may not have been performed. We therefore regard the use of unapproved lasers for refractive surgery as a serious public health problem.

Second, with respect to "gray market" lasers, many of the physicians who imported these lasers communicated their belief to the agency that their lasers were the same as the approved Summit lasers. FDA attempted, in the exercise of its enforcement discretion, to resolve the matter and accommodate these physicians by providing an opportunity for them to certify that their lasers were identical in all relevant aspects to approved lasers.

Specifically, the FDA has already asserted its jurisdiction over problems that are caused by "a laser beam that has a relatively small optical zone, has considerable inhomogeneity, and produces a non-spherical ablation pattern." I have provided sufficient evidence that reusing Microkeratome blades and the Nidek EC5000 laser (the labeling even states that 69% of patients have night driving difficulty) causes these injuries. Many other FDA approved medical devices do as well. The FDA is aware that these injuries are Not reported to the FDA properly either during the clinical trials OR after these devices are approved.

“This penalty sends a clear message that FDA will not tolerate conduct that can put patients at risk and erode the trust between research subjects and the medical research community,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D.

http://www.slackinc.com/eye/jrs/vol115/news1.htm
4. U.S. marshals have seized unapproved lasers from the
following locations:
* June 9 -- Photon Data Inc., Winter Park, Fla. -- Nine
unapproved excimer lasers and components valued at over $3
million seized at two company locations.
* July l -- Woodhams Eye Clinic, Atlanta, Ga. -- One
unapproved excimer laser seized from the office of J. Trevor
Woodhams, M.D.
* August 28 -- Neumann Eye Institute, Deland, Fla. -- One
unapproved excimer laser seized from the office of Albert C.
Neumann, M.D.
* August 28 -- Pro Cargo, Miami, Fla. -- One additional
unapproved excimer laser manufactured by Photon Data Inc. seized
at this private freight forwarder.
* Sept. 2 -- St. George Corrective Vision Center, Chicago,
Ill. -- One unapproved excimer laser seized from the office of
Nicholas Caro, M.D.
In the past three years, FDA has issued 24 warning letters
to manufacturers and physicians regarding the sale and use of
unapproved excimer lasers. The agency is continuing to
investigate this activity and plans to take additional
enforcement action.
Only two lasers are currently approved by FDA for refractive
eye surgery. They are manufactured by Summit Technology, Inc.,
of Waltham, Mass., and VISX, Inc., of Santa Clara, Calif. Both
companies conducted clinical studies to demonstrate that their
lasers could treat nearsightedness safely and effectively using a
procedure called photo refractive keratectomy (PRK).

Audience: Psychiatrists, Pharmacists
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